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| Product NDC Code | 57627-204 | ||||||||||
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| Drug Name | Anti-aging complex broad spectrum spf 30 |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | CREAM | ||||||||||
| Application Number | part352 | ||||||||||
| Labeler Name | Merle Norman Cosmetics, Inc. | ||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Purpose Avobenzone 3.0% Sunscreen Homosalate 8.0% Sunscreen Octisalate 4.0% Sunscreen Octocrylene 2.35% Sunscreen Oxybenzone 5.0% Sunscreen
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions For sunscreen use: apply liberally and evenly 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor Apply to cleansed and toned skin prior to sun exposure.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Aqua/Water/Eau, Glycerin, Ethoxydiglycol, Butylene Glycol, Alcohol Denat., Cyclopentasiloxane, Glycereth-26, Isostearyl Neopentanoate, Nylon-12, Glyceryl Stearate, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Isononyl Isononanoate, Phenoxyethanol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Polymethyl Methacrylate, Hydrolyzed Malt Extract, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, Hydrogenated Lecithin, PEG-100 Stearate, Caprylyl Glycol, Mica (CI 77019), Coco-Glucoside, Ethylhexylglycerin, Tetrasodium EDTA, Xanthan Gum, Coconut Alcohol, BHT, Bisabolol, Hexylene Glycol, Propylene Glycol, Caprylyl/Capryl Glucoside, Opuntia Ficus-Indica Stem Extract, Hydroxypropyl Cyclodextrin, Acetyl Tyrosine, Phospholipids, Panax Ginseng Root Extract, Camellia Sinensis Leaf Extract, Proline, Silica, Adenosine Triphosphate, Hydrolyzed Vegetable Protein, Acetyl Octapeptide-3, Equisetum Arvense Extract, Acetylarginyltryptophyl Diphenylglycine, Ascorbyl Palmitate, Retinyl Palmitate, Palmitoyl Tripeptide-38, Tocopheryl Acetate.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Stop use and ask a doctor if rush occurs.
Purpose
Information about the drug product’s indications for use.Uses helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging by the sun
Spl product data elements
Usually a list of ingredients in a drug product.ANTI-AGING COMPLEX BROAD SPECTRUM SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE OXYBENZONE OXYBENZONE GLYCERYL MONOSTEARATE BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE ISONONYL ISONONANOATE MICA EDETATE SODIUM XANTHAN GUM GREEN TEA LEAF ASIAN GINSENG WATER BUTYLENE GLYCOL AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE CYCLOMETHICONE 5 GLYCERETH-26 PALMITOYL LYSYLDIOXYMETHIONYLLYSINE ISOSTEARYL NEOPENTANOATE NYLON-12 AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER .ALPHA.-TOCOPHEROL ACETATE EQUISETUM ARVENSE BRANCH PHENOXYETHANOL POLY(METHYL METHACRYLATE; 450000 MW) ACETYL OCTAPEPTIDE-3 PROLINE ASCORBYL PALMITATE DIETHYLENE GLYCOL MONOETHYL ETHER ALCOHOL PEG-100 STEARATE ETHYLHEXYLGLYCERIN COCONUT ALCOHOL CAPRYLYL/CAPRYL OLIGOGLUCOSIDE OPUNTIA FICUS-INDICA STEM ACETYLARGINYLTRYPTOPHYL DIPHENYLGLYCINE VITAMIN A PALMITATE HYDROGENATED SOYBEAN LECITHIN CAPRYLYL GLYCOL ACETYL L-TYROSINE LECITHIN, SOYBEAN GLYCERIN BUTYLATED HYDROXYTOLUENE PROPYLENE GLYCOL LEVOMENOL HEXYLENE GLYCOL SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) TRIPOLYPHOSPHATE ION COCO GLUCOSIDE SILICON DIOXIDE ADENOSINE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.ANTI-AGING COMPLEX EMULSION BROAD SPECTRUM SPF 30 MERLE NORMAN 31 g NET WT. 1.1 OZ. Anti-Aging Comp Emul Anti-Aging Complex bottle
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Questions or comments? 1-800-421-2060 9:00 a.m. - 5:00 p.m. PST
Storage and handling
Information about safe storage and handling of the drug product.Other information protect this product from excessive heat and direct sun
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eye. Rinse with water to remove.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API